The first 18A company transformation apocalypse

The development of new crown drugs is a reasonable extension
of Ascletis' core antiviral research and development capabilities.
At present, a number of domestic new crown oral drug projects have entered the clinical trial stage, and they have
not fought before the battle.
Ascletis chose a different strategy, focusing on overseas and taking into account the domestic market
.
At present, more than tens of thousands of people are infected with the new crown every day in the United States, the market is huge, and it is more convenient
for patients to enroll.
SALES OF NEW CROWN ORAL DRUGS THIS YEAR, PFIZER PAXLOVID IS EXPECTED TO BE $22 BILLION, AND MERK MOLNUPIRAVIR IS EXPECTED TO BE $5-5.
5 BILLION
.
With the pandemic normalizing, Pfizer predicts that sales of oral coronavirus drugs can continue into the next few years
.
For Ascletis, even if it only gets a small share of the international market, it is still a huge space
.

ASC10 (RdRp) has received FDA approval for Phase Ib clinical trials in mild to moderate COVID-19 patients.
Phase I clinical trials in China are also advancing
rapidly.
Through the dual prodrug strategy, the permeability and active metabolite exposure of ASC10 reached 3.
2 times and 2.
1 times
that of Merck Molnupiravir, respectively.
In addition to the RdRp target, Ascletis has also independently developed a 3CL target new crown oral drug, laying the foundation
for the subsequent combination of the two drugs.
Anti-new coronavirus cell experiments have shown that the antiviral activity of ASC11 (3CL) is expected to become the best-in-class 3CL protease inhibitor
for the treatment of new coronary pneumonia.

On October 28, Ascletis announced the signing of an agreement with Pfizer: Ascletis will non-exclusively authorize Pfizer China to use part of Ascletis' ritonavir tablets registration data for new crown drugs in Chinese mainland PAXLOVID and the production and supply of ritonavir tablets in Chinese mainland for Pfizer China under an agreement valid for 5 years
.
In the investor exchange meeting, Ascletis said that communication with Pfizer began in early 2022, which took nine months and went through multiple rounds of due diligence, audits and negotiations
.
Pfizer conducted several audits of Ascletis Ritonavir tablets for process technology, product quality, environmental compliance, etc.
, and after several months, Ascletis' comprehensive strength was recognized
by international pharmaceutical giants.
As we all know, Pfizer has strict selection of its partners and suppliers, long cycles, high technical requirements and strict
compliance requirements.
It can be seen that the barriers to cooperation with Pfizer are quite high
.

PAXLOVID is Pfizer's new crown oral effect drug, which was officially conditionally approved for marketing
in China in February this year.
PAXLOVID is a combination of two drugs, nimatevir/ritonavir, a new coronavirus master protease (MPRO, also known as 3CL protease) inhibitor, which is administered in combination with low doses of ritonavir to help slow down the metabolism or breakdown of nematevir and keep it active in the body for a longer period of time at higher concentrations to help fight the new coronavirus
.
Ritonavir tablets are pharmacokinetic enhancers
of several oral antiviral drugs against viral proteases.
Ascletis' ritonavir tablets were approved for domestic marketing
in September 2021.
Ascletis currently owns the only ritonavir oral tablets produced in China that have been approved for marketing through bioequivalence studies, and its annual production capacity has expanded to approximately 530 million tablets
.

In August this year, before Pfizer and Ascletis reached a cooperation, it had already reached a cooperation with Huahai Pharmaceutical: Huahai provided contract manufacturing services
for Pfizer's new coronavirus treatment PAXLOVID sold in the Chinese mainland market during the agreement period (5 years).
Pfizer provides nimatevir APIs and ritonavir preparations, and Huahai Pharmaceutical is responsible for the production of nirmatervir preparations and completes the combination packaging
.
With the implementation of Pfizer's ritonavir cooperation with Ascletis, PAXLOVID's localized supply in China is ready, and the production capacity of Ascletis and Huahai is very sufficient, thereby improving and ensuring the accessibility and affordability of
PAXLOVID drugs for new crown patients in China.
In September this year, Pfizer PAXLOVID has appeared in the preliminary review list of China's medical insurance negotiations in 2022, and it is expected to enter the Chinese medical insurance directory
at a reduced price.
There is no doubt that after the start of local production of PAXLOVID in China, ritonavir is expected to achieve rapid expansion
.
Pfizer's financial report for the second quarter of 2022 shows that PAXLOVID has a market share of 90% in the United States, and it is expected that PAXLOVID will gain a significant market share
in China after localized production.

Functional cure of chronic hepatitis B